Articles Tagged with ''standards''

Last month, we examined the supply chain. The management of this complex system is a daunting task. That’s why, with this month’s column, we will move the discussion from the system to the standard—specifically, the quality management standard, ISO 9001:2015.

Morgan is a 33-year veteran of ASTM International.

We’ve all heard it before. Someone says, “If you want my opinion...” and they give it to you even after you’ve told them you don’t want it.

It shouldn’t come as a surprise, but even after all these years the ISO9001 quality management system (QMS) requirements still come under attack and mostly from those in the quality profession. I recently read another super critical appraisal of ISO9001 from someone who commented they were on the “front lines.” I’m not sure what front lines they’ve been on, but it’s obviously not the same ones I’ve been on.

Imagine this scenario for two potential hires. Looking to build his résumé and gain some credibility in the quality world, Candidate A takes a few courses on quality from an accredited university, and upon completion receives a certificate in quality systems.

The recent implementation of the new quality management system requirements has generated concerns about many issues including documents and standards. 

Things not working together. We’ve most likely all experienced it or witnessed a friend, colleague or family member struggle with it. Recently, hearing a colleague’s frustration I approached his desk to see what was happening.

ISO 9001:2015 was created as a High Level System (HLS). By virtue of being a HLS, the design of the new standard is for other standards to align themselves accordingly by integrating the elements and changes within the context of the principles required in the elements for 9001.

New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version  of ISO 13485.

Spires succeeds Peter Unger, who served as A2LA’s president and CEO for 20 years and continues to support the association in his position as president emeritus.